Ken -- from your comments, you're more qualified to expound on the issue as most of the bloviators online. This is a difficult subject to discuss with a lot of people for a few reasons. One, as you say, is our overblown sense of entitlement -- both to miracle drugs priced like aspirin, and to zero-risk outcomes. Another is the obvious markup over production costs on new drugs. The third is that drug companies are big and make a lot of (gross) dollars. That's a lot of emotion and misinformation to overcome all at once.

In Canada, by the way, the approval process is such that their access to new drugs can be a year behind the U.S., and some don't make the list. Also, generics are slightly more expensive on average (or so I've read in a few places.)

Canada strongarms US drug companies (blackmails is a better term) by threatening to bust their patents and allow local companies to produce generics. So to at least keep control of their patents, the pharmaceutical companies go along and sell drugs to the Canucks on the cheap.

Which is functionally equivalent, as you point out, to our taxpayers and end users subsidizing those wonderfully inexpensive drugs, because Canadians are so, you know, decent and altruistic. And they, like, care and everything, while US drug companies would rather evryone die and stop pestering them.

To be fair (not that I am the least bit inclined to be so) Canada is not the only nation screwing us in order to give freebies to their own.

I don't know enough to comment much on the price differences between us and other countries, but that is my understanding also. I don't have a problem with negotiating price breaks, it's the threats to break patents that irritate me.

"Victimhood"
That is the source of so many problems. All those labels on products warning you of obvious dangers. All the ambulance chasers. The class action lawsuits against manufactrers of perfectly good products used inappropriately by thrid parties. No one wants to take responsibility for their own actions.

Tripped on the edge of the carpet and broke your arm when you fell? Sue the carpet installer, manufacturer and any one else you can think of. It must have been their fault, couldn't have been yours.

If a drug has a side effect such that 1 in 1000 individuals has a higher chance of, oh say, having a stroke, then no one should be allowed to use it. It is dangerous, dad gum it!

Anyone notice the studies always mentioned an increase of, let's say, 50% (none was that high, most were only 2-5%) in the chance to have that stroke I mentioned above. Sounds impressive. But in a group of 1000 people that means the chance went from 1 to 1.5 people having a stroke. Not much of an increase.

Not only that, but according to Steven Milloy, an increase isn't even considered clinically significant unless it's at least a 300% increase (too many confounding factors in any clinical population).

My GOD! I've been saying this stuff for years!

Ken, you rule!!!!! Thanks for finding this for me.

Steve, you are the first person outside the industry (or are you in the industry?) I ever heard to make the point about Canadian blackmailing. That tactic is in violation of it's WTO obligations, if I'm not mistaken. And yes, generics are more expensive in Canada than in the US.

Current developmental attrition rates (according to industry sources, which don't always get the complete picture) are such that about 1 in 30 compounds that start the human testing phase (which is not the starting point of drug discovery by a long shot) of the approval process make it to market. Most die in Phase I, but even that represents an investment of millions of dollars. Remember, these are chemicals no one has had a reason to make before they become drug candidates. Each pill of an investigational drug has to be custom synthesized in kilogram quantities, so each Phase I failure represents millions of dollars of chemical matter costs alone, not to mention safety testing, chemical stability testing (you want the expiration dates on your meds to be backed up with data, right?), etc., etc. Phase II and Phase III failures represent huge losses in clincal trial investments as well.

Drugs are not like cars. Once you design a car, when you make the next model, you can use the same design for headlights, steering wheels, etc. What if, upon every new model change, every single part in a car had to be re-designed and approved by the NTSB? New cars would be horrendously expensive, and most of us would be driving the equivalent of Model Ts. That's the way it is with drugs, and for a good reason. The reason is that there is mechanism-based toxicity and chemical toxicity. A drug can cause side effects based on how it works (the mechanism). Evolution is efficient, so many designs are used over an over again in different systems. So hitting an enzyme that helps stimulate the inflammatory response may have an impact on the same enzynme's role in the digestive tract, for example.

If mechanistic tox were the only toxicity, then drug development would look more like automotive design. However, each chemical difference in a class of drugs can create other headaches if the particular chemical also reacts with biological molecules in the body other than the intended target. Hence chemical-specific toxicity and the need to test each and every new chemical as if it were the first drug ever made.

As for pricing, we in the US are subsidizing the rest of the world. Japan has higher prices than the EU on average, and the EU varies widely, from Canada-like Spain to Germany where they kinda, sorta maybe allow "free" pricing. Spain often complains about being poor country, and demands low prices (funny how being poor didn't help me negotiate my mortgage). That's not even getting into the problem of parallel importing, where a wholesaler in Spain buys a bunch of drug and re-exports it to Germany, pocketing the price difference. The EU trade rules allow this, but for other goods the government of each indvidual country does not get to set arbitrary prices: pricing for other goods are either market driven free prices, or there is an EU-wide price guideline (eg. for some agricultural products).

Bottom line is the Pharma industry is piss poor at getting the message out. Glaxo is the best, but the industry needs to get off of its collective butt.

John, that's excellent information. Much appreciated.

I manufactured IVD reagents for several years so I'm fairly familiar with the Device approval process. Pharmaceutical approval (hell, everything about pharmaceuticals) is orders of magnitude more involved and I'm glad I don't have to deal with it.

Nothing more that I can add, except that Molly Ivins is a class-A dumbass. That's not really "news," of course, but it bears repeating.